1a. Objectives (from AD-416):
To determine the impact of health-promoting components in foods including oral delivery of probiotic bacteria. In-house research demonstrated that Bb12 has a beneficial immune modulating effect on neonatal pigs with improved epithelial and changes in systemic immune markers. On the basis of these results, similar effects are predicted in humans. The Project Plan has one objective that directly relates to this agreement: To elucidate the mechanisms used by probiotic bacteria to improve respiratory and intestinal mucosal responses to allergens, and correlate intestinal micro-flora composition of pigs and humans with biomarkers of allergic and intestinal disease. The Cooperator is interested in the evaluation of the effects of Bb12 on adults given antibiotics as part of a Phase I study to demonstrate the safety of the strain and improve health outcomes. ARS will acquire nucleic acids from blood and fecal samples from treated subjects to detect specific bacterial genes and patterns of whole blood gene expression as was developed using the pig model. This information will be used by both ARS and the Cooperator to jointly develop studies that focus on the effects of Bb12 on the prevention of intestinal disease.

1b. Approach (from AD-416):
ARS will acquire nucleic acids from blood and fecal samples from treated subjects to detect specific bacterial genes and patterns of whole blood gene expression as was developed using the pig model. This information will be used by both ARS and the Cooperator to jointly develop studies that focus on the effects of Bb12 on the prevention of intestinal disease.

3. Progress Report:
Georgetown University conducted a study to establish the safety of strawberry flavored yogurt supplemented with Bb12 with 40 adults for 10 days. Host colonization by probiotic bacteria was measured throughout the study. Immune cell activation gene expression changes in peripheral blood were determined by real time PCR. The data has been collected and is currently being analyzed.